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NCT02672111 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder
A Phase 3 study of Opioid Use Disorder, sponsored by Braeburn Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 228
- Enrollment target
- 20
- Study locations
NCT02672111: Completed Phase 3 study of Opioid Use Disorder, sponsored by Braeburn Pharmaceuticals.
NCT02672111 is a Phase 3 study of Opioid Use Disorder that has completed, run by Braeburn Pharmaceuticals. The registered enrollment target is 228 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02672111, a Phase 3 study of Opioid Use Disorder, has completed, sponsored by Braeburn Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 228 participants
- Enrollment target
- 20
- Study locations
Study Summary
Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.
Primary Outcome
Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period. Safety Assessments: Adverse events (AEs) and serious adverse events (SAEs)-Overall Safety Population
Conditions Studied
Interventions
- DRUG CAM2038 q1w or q4w exposure to SL BPN/NX
- DRUG CAM2038 q1w or q4w new to BPN treatment
Study Locations (20)
Other
- Newcastle Community Health Services - Newcastle
- Drug & Alcohol Services SA Drug and Alcohol Services - Norwood
- Royal Prince Alfred Hospital - Sydney
- South Eastern Sydney Local Health District (SESLHD) - Sydney
- Center for Misbrugsbehandling - Aarhus
- Behandlingscenter Odense - Odense
- Gemeinschaftspraxis Schnaitmann/Schaffert Salzstrasse - Heilbronn
- Studikum - Zentrum fur Klinische Studien im Praxiszentrum Friedrichsplatz - Kassel
- Klinik fur Abhangiges Verhalten und Suchtmedizin Zentralinstitut - Mannheim
- Psychosoziale Begleitung - Praxis Boniakowski - Regensburg
Alabama
- Parkway Medical Center - Birmingham
- Haleyville Clinical Research LLC - Haleyville
- Boyett Health Services Inc - Hamilton
Florida
- Dr Vijapura and Associates - Jacksonville
- TRY Research - Maitland
New Jersey
- Wellness and Research Center - Belvidere
- Comprehensive Clinical Research - Berlin
Massachusetts
- Stanley Street Treatment and Resources Inc - Fall River
New York
- STARS/Columbia University - New York
Pennsylvania
- Frost Medical Group, LLC - Conshohocken
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2015-11 |
| Est. Completion | 2017-05 |
| Phase | Phase 3 |
What the finished NCT02672111 record still lists
NCT02672111 is an interventional study that assigns participants to a tested intervention. The registered 228 participants enrollment target is mid-sized for trials with a published cap, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Opioid Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which CAM2038 q1w or q4w exposure to SL BPN/NX is the first listed.
NCT02672111 names 20 study sites across 7 states, led by Other, Alabama, Florida.
Frequently Asked Questions
What is clinical trial NCT02672111 about?
NCT02672111 is a clinical study titled "Long-Term Safety Study of Buprenorphine (CAM2038) in Adult Outpatients With Opioid Use Disorder". Open-label multi-center, 48 week safety study, consistent with standard practice for long-term safety studies. This one year safety study will utilize CAM2038 q1w (once weekly) and q4w (once monthly) and will have 3 phases: Screening, Treatment, and Follow-up.
What is the current status of trial NCT02672111?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 228 participants. The study started on 2015-11. Estimated completion is 2017-05.
What conditions does trial NCT02672111 study?
This clinical trial studies the following conditions: Opioid Use Disorder.
What interventions are being tested in trial NCT02672111?
The interventions under investigation include: CAM2038 q1w or q4w exposure to SL BPN/NX (DRUG), CAM2038 q1w or q4w new to BPN treatment (DRUG).
Who is sponsoring clinical trial NCT02672111?
This trial is sponsored by Braeburn Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02672111 being conducted?
This trial has 20 study locations across Alabama, Florida, Massachusetts, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Opioid Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02672111's enrollment target sits among peer trials
228 81st of 257 higher than 177 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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